European Commission communication campaign on the new Regulations on medical devices and in vitro diagnostic medical devices

The Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW) is launching a communication campaign on the new Regulations on medical devices (MDR) and in vitro diagnostic medical devices (IVDR). They came into force on 25 May 2017 and a transitional period is foreseen until May 2020 for medical devices and May 2022 for in vitro diagnostic medical devices.

GOPA Com. has been chosen to undertake a series of targeted communication activities from 2018 onwards.

Although this transitional period seems long, it is essential that all key players on the market are well-aware of the changes brought by these Regulations and already take the necessary steps to ensure their readiness.

The campaign aims at providing information to key actors and increasing awareness on the new requirements and timelines of these Regulations, with the overall objective to avoid any disruption on the market and to prevent any malfunctioning of the healthcare system.

The campaign will primarily focus on manufacturers (and notably SMEs), the "procurement world" (e.g. hospitals, Ministries, etc.), authorised representatives, importers, distributors, re-processors of single-use devices, health institutions, healthcare professionals and authorities in third countries. Due to the number of targets and their worldwide distributions, the communication campaign will mainly be performed online, using notably DG GROW website and the engagement of existing networks of relevant multipliers.

The preparatory work of the communication campaign is ongoing. In this framework, we would like to ask your support, as a main stakeholder in this field, to help spreading the campaign messages and communication materials.

We have therefore put online a short questionnaire that we would kindly ask you to fill in by the 18th of May: https://campaign.gopacom.io/new-regulation-md-questionaire. In case you would like to get additional information from the European Commission, you can contact DG GROW at vincent.houdry@ec.europa.eu.

Thank you in advance for your support.
Best regards,

Fabien Dongradi
EU-Campaigns Team Leader
GOPA Com.
EU-MDRcampaign@gopacom.eu